LEICSTES = LEICeSter Tendon Extracorporeal Shockwave Studies Assessing the Benefits of the Addition of Extra-Corporeal Shockwave Treatment to a Structured Home-rehabilitation Programme for Patients With Tendinopathy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
研究概览
简要总结
To assess whether the addition of Extra-corporeal Shockwave Therapy (ESWT) to a structured home-exercise programme has any additional benefit to patients with tendinopathies
详细描述
This involves patients with one of 6 different defined chronic tendinopathies. These individual sites are run as discrete sub-studies, with randomisation n occurring within sub-study grouping
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age >18
- •Symptoms (typically pain / stiffness) of at least 12 weeks of one of the following sites / conditions:
- •Plantar fasciitis
- •Insertional Achilles tendinopathy
- •Mid-substance Achilles tendinopathy
- •Patella tendinopathy
- •Trochanteric pain syndrome (gluteus medius insertional tendinopathy / trochanteric bursitis)
- •Tennis elbow
- •Referred for ESWT (shockwave) within the Sports Medicine Department
- •Objective imaging of tendon / structure confirming diagnosis and excluding tear or other structural injury (US or MRI acceptable)
排除标准
- •Patients with the normal exclusions for ESWT - including pre-existing skin injury over tendon site, recent steroid injection (within 6 weeks of ESWT starting), patients on anticoagulation, patients with haemophilia or other bleeding tendency, patients with current febrile illness
- •Previous ESWT treatment for the same condition
研究组 & 干预措施
intervention
rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy)
干预措施: Extra-Corporeal Shockwave Therapy (ESWT) (Device)
intervention
rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy)
干预措施: structured rehabilitation programme (Other)
control
rehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy)
干预措施: structured rehabilitation programme (Other)
结局指标
主要结局
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
时间窗: primary outcome 3 months
次要结局
- improvement in pain as assessed by a 0-10 visual analogue scale (VAS)(secondary outcome at 6 months post treatment)
- improvement in function as assessed by several validated patient-rated outcome measures(3 months and 6 months)